Lupin Mandideep Plant, Oct 31, 2023 · Drug firm Lupin on Tuesday said it has received Establishment Inspection Report (EIR) from the U. FDA inspection of its Mandideep Unit II facility, classifying the inspection as Voluntary Action Indicated. FDA). 124 and 2201/2202, GIDC Estate, Ankleshwar Ankleshwar 393002 Bharuch Gujarat Tel: 02646-304203 /304204 Plant Lupin Research Park, Survey No. The inspection of the facility conducted from August 7 to August 11, 2023, Lupin said in a regulatory filing. Lupin, a Mumbai-based mid-tier pharma company has said the US Food and Drug Administration (US FDA) has cleared its Mandideep drug factory after inspections. Find company research, competitor information, contact details & financial data for LUPIN LIMITED of Mandideep, Madhya Pradesh. New Delhi: Drug maker Lupin on Thursday said the US health regulator has issued Form-483 with eight observations each for product and raw material production centres at its Mandideep-based Drug firm Lupin on Tuesday said it has received Establishment Inspection Report (EIR) from the U. The inspection closed with the Mumbai: Global pharma major Lupin Limited has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U. M/s Lupin Limited, Mandideep, has proposed expansion of its product spectrum and manufacturing capacity, within the existing factory premises at village Mandideep, Tehsil Goharganj, District Raisen. According to the regulator, the status means Lupin Ltd, Mandideep manufacturing plant, India. 45"E. in Mandideep - Find its location, contact details, and more with our interactive map. 464551 Pune Office no. It is primarily a manufacturer of generic drugs, covering therapeutic areas such as paediatrics, cardiovascular, anti-infectives, diabetology, asthma and anti-tuberculosis. 34"N and Longitude 77°32’0. Food and Drug Administration (USFDA) issues an EIR to a company when an inspection is satisfactorily closed Mumbai, October 31, 2023: Global pharma major Lupin Limited (Lupin) today announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U. The facility employs ~450 people and manufactures various dosage forms like tablets, capsules and suspension in the dosage forms. The EIR was issued post the last inspection of the facility conducted from August 7 to August 11, 2023. Nov 24, 2022 · The USFDA had inspected the Mandideep Unit-1 facility in Madhya Pradesh from November 14, 2022, to November 23, 2022, the Mumbai-based drug maker said in a regulatory filing. 59. P. The United States Food & Drugs Administration (USFDA) has begun inspecting Lupin's unit at Mandideep on Tuesday, sources have exclusively told CNBC-TV18. Looking for Lupin Labs. Our culture, defined by our values, translates into an invigorating environment that mentors, nurtures and supports talented individuals in their journey from good to great. On October 31, the pharmaceutical company Lupin announced that the US health authorities had issued an Establishment Inspection Report (EIR) for its Mandideep Unit-2 manufacturing facility in Madhya Pradesh. Get the latest business insights from Dun & Bradstreet. A warning letter was issued to the said unit by the US drug regulator in 2019. Lupin's manufacturing plant in Mandideep, Madhya Pradesh, India, was classified as No Action Indicated by the US Food & Drug Administration in August. Mumbai, India, August 12, 2023: Global pharma major Lupin Limited (Lupin) today announced that its Unit-2 manufacturing facility located in Mandideep, India, has successfully completed a GMP inspection by the United States Food and Drug Administration (U. Unit II of the said unit had received an Establishment Inspection Connect with Lupin. USFDA issues Form 483 with 8 observations to Lupin Mandideep plant: FDA has inspected Lupin’s Mandideep Unit-1, Bhopal, Madhya Pradesh facility from The United States Food and Drug Administration (USFDA) has closed its current inspection at Indian drugmaker Lupin's Mandideep Unit-1 facility. 201 Mumbai: Global pharma major Lupin Limited has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U. 46A/47A, Nande Village, Mulshi Taluka Pune 411042 Pune Maharashtra Tel: 020 6674 9100 Global pharma major Lupin Limited (Lupin) today announced that its Unit-2 manufacturing facility located in Mandideep, India, has successfully completed a GMP inspection by the United States Food and Drug Administration (U. Lupin’s flagship facility, the Aurangabad plant, started operations in 1979. It fell in a form of a warning letter Drug maker, Lupin, received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Mandideep Unit-2 facility in Madhya Pradesh. Global pharma major Lupin Limited (Lupin) today announced that its Unit-2 manufacturing facility located in Mandideep, India, has successfully completed a GMP inspection by the United States Food and Drug Administration (U. Our workplace policies and initiatives are designed to enable our employees’ personal and Lupin's Mandideep plant comes under FDA scanner Lupin has received a total of three observations relating to violation of production norms at manufacturing facilities at its Mandideep plant in Madhya Pradesh from the US Food and Drug Administration(USFDA). 424001 Alwar 134, Alkapuri Alwar Pin Code: 301001 Sindhudurg Flat No 404, Saiserenia Building, Mathewada, Sawantwadi, Block- Sawantwadi, Dist- Sindhudurg 416510, Maharashtra Mandideep Plot No-196-202, New Industrial Area, Mandideep, Dist Raisen-M. Apply online for jobs at Lupin Ltd The Spirit of Lupin powers our people and our operating universe, essentially our Work Family. Lupin is a global pharmaceutical company from India, advancing healthcare through innovation, research and accessible medicines globally. FDA) for its Mandideep Unit-2 manufacturing facility. When an inspection is satisfactorily concluded, the US Food and Drug Administration (USFDA) awards an EIR to a company. Global pharma major Lupin Limited (Lupin) has announced that its Unit-2 manufacturing facility located in Mandideep, India, has successfully completed a GMP inspection by the United States Food and Drug Administration (U. Lupin Limited is an Indian multinational pharmaceutical company based in Mumbai. “We are pleased to Oct 31, 2023 · Lupin Mandideep plant gets green signal from USFDA The US Food and Drug Administration (USFDA) issues an EIR to a company when an inspection is satisfactorily closed. The inspection at this facility was initiated after issuing a form 483 with 16 observations. "The inspection of the facility closed with issuance of a Form-483 with eight observations each for the drug product facility and active pharmaceutical ingredient (API) facility at the site," it added. Plant 198-202, New Industrial Area 2 Mandideep Mandideep 462046 Raisen Madhya Pradesh Tel: 07480 410 800 Plant Plot Nos. health regulator for its Mandideep Unit-2 manufacturing facility in Madhya Pradesh. The inspection closed with the facility receiving an inspection classification of "No Action Indicated" (NAI). Ltd. 321001 Dhule 28/A Sharadha Nagar, Deopur, Datta Mandir, Dhule. NEW DELHI: Drug major Lupin today said it has received a total of three observations relating to violation of production norms at manufacturing facilities at Mandideep, Madhya Pradesh from the US Food and Drug Administration. Nov 1, 2023 · Lupin has received Establishment Inspection Report (EIR) from the US health regulator for its Mandideep Unit-2 manufacturing facility in Madhya Pradesh. These are reflected in Lupin India’s growing capabilities. Lupin Ltd, Pune Biotech Manufacturing Facility, India. ALL RIGHTS RESERVED 2/2 Mumbai, India: Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) after closure of the U. A fourth Lupin manufacturing facility in India has been slapped by the FDA with a Form 483 notice, citing eight issues at its API plant in Mandideep. In 2019, its plant in Mandideep, India, was hit with a warning letter that flagged a variety of manufacturing and data safety issues. The U. By 1992, Lupin had set up a fermentation plant at Tarapur and a sterile plant for injectable Cephalosporins at Mandideep. Find contact details for offices, investor support, media queries and customer assistance to get help or information quickly. The site address is Plot 198-202, Sector-II, New Industrial area, Mandideep, Months after the FDA demanded Lupin act on failures at its Mandideep, India finished dose plant, the Indian drugmaker was waiting for the other shoe to fall. Feb 4, 2026 · Global pharma major Lupin Limited (Lupin) today announced that its Unit-2 manufacturing facility located in Mandideep, India, has successfully completed a GMP inspection by the United States Food and Drug Administration (U. Bharatpur 239, Krishna Nagar, Bharatpur Rajasthan, India. The drug regulator issued eight observations each on a drug . Lupin has often been a target for FDA scrutiny. © LUPIN. The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations. S. jezh, ab66tj, 6ji2, xebchp, dnxy3, v1ml, y9dvtr, sn2aq, 4yfl8, dukrv,